Events

Retiro De Equipo (Recall) de Bio-Absorbable Suture Anchors (Soft tissue fixation device)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Surgical Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00844-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-08-08
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00844-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Smith & nephew advises that bio-absorbable suture anchors with the affected catalogue numbers are being recalled due to a packaging issue. specifically, pin holes and/or tiny slits (0.5mm - 5.0mm) have been identified in a small number of the primary pouches that may constitute a breach of the sterile barrier.
  • Acción
    Smith & Nephew is requesting users to inspect stock and remove any affected sutures for replacement.

Device

Bio-Absorbable Suture Anchors (Soft tissue fixation device)
  • Modelo / Serial
    Bio-Absorbable Suture Anchors (Soft tissue fixation device)Part Numbers: 7220257, 72202602, 72202603, 72202624, 72202626, 72200775, 72201991, 72202165, 72201992, 72201996, 72201993, 72201994 and 72201995ARTG Numbers: 181234, 181413, 161696, 164725, 164726 and 164727
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd